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Generated: December 17, 2018

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Details for New Drug Application (NDA): 202191

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NDA 202191 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Roxane, Teva, Vistapharm, Wockhardt Bio Ag, Novel Labs Inc, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Par Pharm Inc, Sandoz, Schering, Sun Pharm Industries, Superpharm, Usl Pharma, Vintage Pharms, Watson Labs, and Yaopharma Co Ltd, and is included in fifty-three NDAs. It is available from forty-three suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 202191
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Novel Labs Inc
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202191
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 202191
Suppliers and Packaging for NDA: 202191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202191 ANDA Novel Laboratories, Inc. 40032-580 40032-580-31 10 BLISTER PACK in 1 CARTON (40032-580-31) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202191 ANDA Novel Laboratories, Inc. 40032-581 40032-581-31 10 BLISTER PACK in 1 CARTON (40032-581-31) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Aug 15, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Aug 15, 2014TE:RLD:No

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